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Ulcers Formation After Hand-Sewn vs Stapled Gastrojejunal Anastomosis In MGB.

NCT06077955 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-04-02

No results posted yet for this study

Summary

We assume that the frequency of gastrojejunostomy ulcers after MGB-OAGB is associated with the peculiarities of the side-to-side gastrojejunostomy (GJS) formation, which is currently the "gold standard" for this procedure. The geometry of such anastomosis leads to the formation of a narrow strip of the gastric wall between two stapler lines (between the suture from the 2nd cassette during the formation of the "small ventricle" and directly from the suture from the cassette during the GJS formation). Perhaps this section of the stomach wall is prone to ischemia, which can certainly increase the risk of ulcer formation. It is also possible that a zone with impaired blood supply may also form in the "blind pocket" above the anastomosis.

When forming a Hand-Sewn GJS of the end-to-side type, ischemia zones do not occur. The anastomosis has a more physiological geometry, there is no conflict between the lines of stapled sutures.

Thus, we put forward the assumption that a serious risk factor for the development of a GJS ulcer was eliminated when switching to a completely manual technique for the GJS formation when performing MGB-OAGB.

The study is aimed at the compare the incidence of GJS ulcers during MGB-OAGB, depending on the techniques of anastomosis formation.

Conditions

  • Ulcer Peptic

Interventions

PROCEDURE

Mini-gastric bypass with stapled anastomosis

the stomach is transected using linear endoscopic staplers in such a way as to create an isolated narrow gastric tube ("small ventricle") at least 17-18 cm long and 15-20 mm wide (diameter of gastric tube used 36-39 Fr). • A gastroenterostomy is performed at a distance of 150-200 cm from the ligament of Treitz using a linear stapler.

PROCEDURE

Mini-gastric bypass with hand-sewn anastomosis

the stomach is transected using linear endoscopic staplers in such a way as to create an isolated narrow gastric tube ("small ventricle") at least 17-18 cm long and 15-20 mm wide (diameter of gastric tube used 36-39 Fr). • A gastroenterostomy is performed at a distance of 150-200 cm from the ligament of Treitz using a fully manual suture.

Sponsors & Collaborators

  • Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

    lead OTHER

Principal Investigators

  • Aleksandr Neimark, MD, PhD · Almazov National Medical Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-04-30
Completion
2025-04-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06077955 on ClinicalTrials.gov